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Life Sciences Companies Face Continuing Compliance Challenges in Developing Value-Based and Value-Added Models

By Samuel C. Bernstein, Kristen H. Chang & McGuireWoods LLP on December 28, 2023
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FCA-OIG-Advisory-Opinion

The U.S. Department of Health and Human Services Office of Inspector General recently issued Advisory Opinion 23-08, continuing its long-held position that the provision of value-added items and services implicates fraud and abuse laws, including the Federal Anti-Kickback Statute and the Beneficiary Inducement Civil Monetary Penalty law.

Read on to learn how manufacturers, distributors, and other life sciences companies that seek to improve outcomes by providing value-added items and services to their customers continue to face challenges in developing compliant models.

Photo of Samuel C. Bernstein Samuel C. Bernstein

Sam focuses his practice on healthcare regulatory compliance, general corporate representation of healthcare providers and suppliers, contract negotiation, and transactional matters.

Read more about Samuel C. BernsteinEmail
Photo of Kristen H. Chang Kristen H. Chang

Kristen assists clients in traversing regulatory, compliance, corporate transactional, and reimbursement issues related to the healthcare industry. She counsels clients on the federal Anti-Kickback Statute, Stark Law, Medicare policy, state fraud and abuse laws, state corporate practice of medicine laws, state licensure laws…

Kristen assists clients in traversing regulatory, compliance, corporate transactional, and reimbursement issues related to the healthcare industry. She counsels clients on the federal Anti-Kickback Statute, Stark Law, Medicare policy, state fraud and abuse laws, state corporate practice of medicine laws, state licensure laws, HIPAA, fee-splitting prohibitions, and other regulatory matters.

Read more about Kristen H. ChangEmail
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McGuireWoods LLP

At McGuireWoods, we deliver quality work, personalized service and exceptional value. We use technology to provide efficient legal solutions and employ a diverse workforce to bring real-world and innovative perspectives to meeting our clients’ needs. With 1,100 lawyers and 21 strategically located offices…

At McGuireWoods, we deliver quality work, personalized service and exceptional value. We use technology to provide efficient legal solutions and employ a diverse workforce to bring real-world and innovative perspectives to meeting our clients’ needs. With 1,100 lawyers and 21 strategically located offices worldwide, McGuireWoods uses client-focused teams to serve public, private, government and nonprofit clients from many industries, including automotive, energy resources, healthcare, technology and transportation.

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  • Posted in:
    Administrative, Corporate & Commercial
  • Blog:
    The FCA Insider
  • Organization:
    McGuireWoods LLP
  • Article: View Original Source

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